Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2008-03-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A1
BMS-582949
Tablets, Oral, 300 mg, once daily, 12 weeks
P1
Placebo
Tablets, Oral, placebo, once daily, 12 weeks
Interventions
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BMS-582949
Tablets, Oral, 300 mg, once daily, 12 weeks
Placebo
Tablets, Oral, placebo, once daily, 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
* Must have at least 6 swollen and at least 8 tender joints
* CRP above upper limit of normal or ESR \> 28 mm/hr
* Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication
Exclusion Criteria
* Recent infection requiring antibiotics within 4 weeks
* History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
* Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Desert Medical Advances
Palm Desert, California, United States
Orrin M. Troum,M D
Santa Monica, California, United States
G. Timothy Kelly, Md
Las Vegas, Nevada, United States
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States
The Arthritis Group
Philadelphia, Pennsylvania, United States
Arthritis Clinic
Jackson, Tennessee, United States
Walter F Chase Md
Austin, Texas, United States
Tacoma Center For Arthritis Research Ps
Tacoma, Washington, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Local Institution
České Budějovice, , Czechia
Local Institution
Hradec Králové, , Czechia
Local Institution
Prague, , Czechia
Local Institution
Bordeaux, , France
Local Institution
Chambray-lès-Tours, , France
Local Institution
Paris, , France
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Nuevo León, Nuevo León, Mexico
Local Institution
Culiacán, Sinaloa, Mexico
Local Institution
Cheonan, Choong Chung Nam-Do, South Korea
Local Institution
Madrid, , Spain
Local Institution
Santiago de C., , Spain
Local Institution
Vizcaya, , Spain
Local Institution
Taichung, , Taiwan
Local Institution
Taoyuan District, , Taiwan
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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IM119-015
Identifier Type: -
Identifier Source: org_study_id
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